FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80977–81000 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2000
PRECIMED TRAUMA SYSTEM
K002486 · HRS
Patrick Berdoz
Orthopedic · 87d
Cleared Nov 09, 2000
FETALGARD LITE
K002503 · HGM
Analogic Corp.
Obstetrics & Gynecology · 87d
Cleared Nov 09, 2000
ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3
K002687 · LDF
Zynergy Cardiovascular, Inc.
Cardiovascular · 72d
Cleared Nov 09, 2000
CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
K002693 · EBL
Cbs Intl. B.V.
Dental · 72d
Cleared Nov 09, 2000
FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K002720 · LYY
Tillotson Healthcare Corp.
General Hospital · 70d
Cleared Nov 09, 2000
KENDRO HERACELL CO2 INCUBATOR
K002805 · MQG
Kendro Laboratory Products, L.P.
Obstetrics & Gynecology · 62d
Cleared Nov 09, 2000
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K003179 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 29d
Cleared Nov 08, 2000
ETEST LINEZOLID
K002139 · LTX
Ab Biodisk
Microbiology · 114d
Cleared Nov 08, 2000
PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH
K002459 · DPS
Agilent Technologies, Inc.
Cardiovascular · 90d
Cleared Nov 08, 2000
STELLAR
K002463 · FSY
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 90d
Cleared Nov 08, 2000
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
K002473 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 89d
Cleared Nov 08, 2000
BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH...
K002499 · BZG
Brentwood Medical Technology Corp.
Anesthesiology · 86d
Cleared Nov 08, 2000
CERAM-PRIME
K002502 · KLE
S & C Polymer GmbH
Dental · 86d
Cleared Nov 08, 2000
FREEDOM AUTOMATIC FILM PROCESSOR
K002640 · IXW
J. Morita USA, Inc.
Radiology · 76d
Cleared Nov 08, 2000
PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING
K002707 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 70d
Cleared Nov 08, 2000
CARESIDE CHOLINESTERASE
K002792 · DIH
Careside, Inc.
Chemistry · 62d
Cleared Nov 08, 2000
IRIS RETRACTING PHACOEMULSIFICATION SLEEVE
K002812 · HQC
Michael Reynard, M.D.
Ophthalmic · 61d
Cleared Nov 08, 2000
OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B)...
K002966 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 47d
Cleared Nov 08, 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K003167 · DQA
Masimo Corp.
Anesthesiology · 29d
Cleared Nov 08, 2000
PERSONAL ECG TRANSMITTER, MODEL CG-6550
K003220 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 23d
Cleared Nov 08, 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP...
K003244 · DQA
Masimo Corp.
Anesthesiology · 22d
Cleared Nov 08, 2000
PCCR DIGITAL IMAGING DEVICE
K003256 · MQB
Orex Computed Radiography, Ltd.
Radiology · 22d
Cleared Nov 08, 2000
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER...
K003315 · JOH
Mallinckrodt, Inc.
Anesthesiology · 16d
Cleared Nov 08, 2000
QWH-149 WRIST ARRAY COIL
K003331 · MOS
Mri Devices Corp.
Radiology · 15d